Apparatus and method for sensor deployment and fixation

ABSTRACT

A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of, and claimspriority to, U.S. application Ser. No. 16/162,147, Titled “APPARATUS ANDMETHOD FOR SENSOR DEPLOYMENT AND FIXATION” which was filed on 16 Oct.2018, the complete subject matter of which is expressly incorporatedherein by reference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to implantation of intracorporealdevices into vessels and to systems and methods of delivering suchintracorporeal devices to predetermined locations within the vessel.

BACKGROUND

In recent years, the long-sought goal of implantable biosensors hasbegun to see realization and, in some cases, clinical use. As thisconcept has seen continued research and development, issues regardingintracorporeal fixation of the sensor have come to light. Particularlywithin blood vessels, the sensor is subjected to a continuous, pulsatileflow. This is a difficult environment in which to secure a sensor orother apparatus reliably without unduly restricting blood flow orimpairing the vessel wall. One major vessel of interest in the realm ofcardiology is the pulmonary artery. The pulmonary artery is aparticularly challenging location in which to secure an intracorporealdevice because, in addition to the above considerations, the vessel isespecially thin, compliant and prone to perforation.

Design considerations for an ideal fixation device intended forintravascular fixation are outlined as follows. The fixation deviceshould be passive and maintain a separation distance between the sensorand the vessel wall to maintain blood flow past the sensor. The deployedsize and radial strength of the device should be sufficient to preventits migration into vessels that would be occluded by the dimensions ofthe sensor while creating minimal stress concentrations where thefixation device contacts the vessel wall. Alternatively, intracorporealdevices can be designed sufficiently small in size so that when deployedin organs or regions with sufficiently redundant blood flow, the devicecan embolize on its own without harming the organ or the host. Finally,the fixation device should be sufficiently versatile as not to depend,within physiologically relevant ranges, on the size of the vessel inorder to maintain its position.

Thus, a need exists for devices and methods for fixing intracorporealdevices and, in particular, for delivery and fixation of such devices ina safe, simple and predictable manner.

SUMMARY

In one aspect of the present disclosure, an intracorporeal devicedelivery system is provided. The delivery system includes a deliveryshaft including a distal coupling feature and a sheath adapted toreceive a guidewire and defining a delivery shaft lumen, the deliveryshaft being disposed within the delivery shaft lumen. The deliverysystem further includes an intracorporeal device having a proximalcoupling feature and a device body, the device body defining an axialenvelope extending proximally from the device body. The distal couplingfeature is releasably coupled to the proximal coupling feature suchthat, when coupled, the distal coupling feature is disposed within theaxial envelope defined by the device body.

In certain implementations, the sheath defines a guidewire lumenseparate from the delivery shaft lumen and shaped to receive theguidewire.

In another implementation, the distal coupling feature of the deliveryshaft is a threaded extension extending distally from the delivery shaftand the proximal coupling feature of the intracorporeal device is athreaded hole shaped to receive the distal coupling feature.

In yet another implementation, the intracorporeal device delivery systemfurther includes a hub coupled to a proximal end of the delivery shaft.The hub may include a shaft manipulation feature coupled to the deliveryshaft and configured to release the distal coupling feature from theproximal coupling feature when manipulated. In one exampleimplementation, the shaft manipulation feature is a rotatable knobcoupled to the delivery shaft such that rotation of the rotatable knobrotates the delivery shaft to decouple the distal coupling feature fromthe proximal coupling feature.

In certain implementations, the hub includes at least one port incommunication with an auxiliary lumen of the sheath such that the portis in fluid communication with a distal end of the sheath. The auxiliarylumen may, in some implementations, be one of the distal shaft lumen orthe guidewire lumen.

The sheath may, in certain implementations, include braided tubing, suchas Pebax tubing.

In certain implementations, the intracorporeal device includes a guidedefining a passage shaped to receive the guidewire, the passage disposedoutside the axial envelope.

In another aspect of the present disclosure, an intracorporeal devicedelivery system is provided. The delivery system includes a deliveryshaft including a distal coupling feature extending from a distal end ofthe delivery shaft and including a threaded extension. The deliverysystem further includes a sheath adapted to receive a guidewire anddefining a delivery shaft lumen, the delivery shaft being disposedwithin the delivery shaft lumen. The delivery system also includes anintracorporeal device having a proximal coupling feature and a devicebody, the device body defining an axial envelope extending proximallyfrom the device body and the proximal coupling feature including athreaded hole shaped to receive the threaded extension of the deliveryshaft. The distal coupling feature is releasably coupled to the proximalcoupling feature such that, when coupled, the distal coupling feature isdisposed within the axial envelope defined by the device body.

In certain implementations, the sheath defines a guidewire lumenseparate from the delivery shaft lumen and shaped to receive theguidewire.

In another implementation, the distal coupling feature of the deliveryshaft is a threaded extension extending distally from the delivery shaftand the proximal coupling feature of the intracorporeal device is athreaded hole shaped to receive the distal coupling feature.

In yet another implementation, the intracorporeal device delivery systemfurther includes a hub coupled to a proximal end of the delivery shaft.The hub may include a rotatable knob coupled to the delivery shaft suchthat rotation of the rotatable knob rotates the delivery shaft todecouple the distal coupling feature from the proximal coupling feature.In certain implementations, the rotatable knob may be coupled to thedelivery shaft by a set screw extending through the rotatable knob.

In certain implementations, the hub includes at least one port incommunication with an auxiliary lumen of the sheath such that the portis in fluid communication with a distal end of the sheath. The auxiliarylumen may, in some implementations, be one of the distal shaft lumen orthe guidewire lumen.

The sheath may, in certain implementations, include braided tubing, suchas Pebax tubing.

In certain implementations, the intracorporeal device includes a guidedefining a passage shaped to receive the guidewire, the passage disposedoutside the axial envelope.

In yet another aspect of the present disclosure, an intracorporealdevice delivery system is provided. The delivery system includes asheath defining each of a delivery catheter lumen and a guidewire lumenseparate from the delivery catheter lumen and a delivery catheterextending through at least a portion of the delivery catheter lumen. Thesystem further includes an intracorporeal device releasably coupled to adistal portion of the delivery catheter and a hub coupled to a proximalend of the sheath, the hub including a port. A cross-sectional area ofthe delivery catheter lumen exceeds a cross-sectional area of thedelivery catheter such that an annular volume is defined between thedelivery catheter and an inner wall of the delivery catheter definingthe delivery catheter lumen, the annular volume being in communicationwith the port.

Other objects, features, and advantages of the present disclosure willbecome apparent upon reading the following specification, when taken inconjunction with the drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of aspects of this disclosure can be obtained, amore particular description of the implementations briefly describedabove will be rendered by reference to specific embodiments thereofwhich are illustrated in the appended drawings. It should be noted thatthe figures are not drawn to scale, and that elements of similarstructure or function are generally represented by like referencenumerals for illustrative purposes throughout the figures. Thesedrawings depict only example implementations of the present disclosureand are not therefore to be considered to be limiting of its scope.Implementations of the disclosure will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings.

FIG. 1 is an isometric view of a first embodiment of an implant assemblyaccording to the present disclosure, the implant assembly having twoopposed wire loops.

FIG. 2 is a top view of the implant assembly of FIG. 1 .

FIG. 3 is a cutaway view of a vessel showing the implant assembly ofFIG. 1 fixed therein.

FIG. 4 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 1 fixed therein.

FIG. 5 is a top view of a second embodiment of an implant assemblyaccording to the present disclosure, the implant assembly having opposedwire loops.

FIG. 6 is a cutaway view of a vessel showing the implant assembly ofFIG. 5 fixed therein.

FIG. 7 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 5 fixed therein.

FIG. 8 is a top view of a third embodiment of an implant assemblyaccording to the present disclosure, the implant assembly having twoopposed wire loops.

FIG. 9 is an isometric view of the implant assembly of FIG. 8 .

FIG. 10 is a cutaway view of a vessel showing the implant assembly ofFIG. 8 fixed therein.

FIG. 11 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 8 fixed therein.

FIG. 12 is a top view of a fourth embodiment of an implant assemblyaccording to the present disclosure, the implant assembly having opposedwire loops.

FIG. 13 is an isometric view of the implant assembly of FIG. 12 .

FIG. 14 is a cutaway view of a vessel showing the implant assembly ofFIG. 12 fixed therein.

FIG. 15 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 12 fixed therein.

FIG. 16 is an isometric view of a seventh embodiment of an implantassembly according to the present disclosure, the implant assemblyhaving a radial wire array expansible structure.

FIG. 17 is a cutaway view of a vessel showing the implant assembly ofFIG. 16 fixed therein.

FIG. 18 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 16 fixed therein.

FIG. 19 is an isometric view of an eighth embodiment of an implantassembly according to the present disclosure, the implant assemblyhaving a daisy petal wire expansible structure.

FIG. 20 is an isometric view of a ninth embodiment of an implantassembly according to the present disclosure, the implant assemblyhaving a daisy petal expansible structure on each end of anintracorporeal device.

FIG. 21 is an isometric view of a tenth embodiment of an implantassembly of the present disclosure, the implant assembly having a daisypetal wire expansible structure.

FIG. 22 is an isometric view of an eleventh embodiment of an implantassembly according to the present disclosure, the implant assemblyhaving a daisy petal wire expansible structure.

FIG. 23 is a cutaway view of a vessel showing the implant assembly ofFIG. 19 fixed therein.

FIG. 24 is a cutaway view of a pulmonary arterial vessel showing theimplant assembly of FIG. 19 fixed therein.

FIG. 25 is a side cross-sectional view of a first embodiment of adelivery apparatus according to the present disclosure.

FIG. 26 is a side view of a tether wire of the delivery apparatus ofFIG. 25 .

FIG. 27 is a side view of a core wire of the delivery apparatus of FIG.25 .

FIG. 28 is a side view of a guidewire of the delivery apparatus of FIG.25 .

FIG. 29 is a side cross-sectional view of the delivery system of FIG. 25with an implant assembly coupled thereto.

FIG. 30 is a side cross-sectional view of a second embodiment of adelivery system for delivering an intracorporeal device such as thatshown in FIG. 5 .

FIG. 31 is a side cross-sectional view of a distal portion of a thirdembodiment of a delivery system for delivering an intracorporeal devicesuch as that shown in FIG. 5 .

FIG. 32 is a side elevation view of a proximal portion of the deliverysystem of FIG. 31 .

FIGS. 33-34 are cross-sectional views of sheaths that may be used in thedelivery system of FIG. 31 .

FIG. 35 is a cross-section view of the sheath of FIG. 34 including adelivery catheter and a guidewire disposed therein.

FIG. 36 is a side elevation view of a distal portion of a deliverysystem including an intracorporeal device.

FIG. 37 is a side elevation view of the distal portion of the deliverysystem of FIG. 36 excluding the intracorporeal device.

FIG. 38 is a side elevation view of a proximal portion of the deliverysystem of FIGS. 36-37 .

DETAILED DESCRIPTION

An implant assembly as described in this disclosure generally includesan intracorporeal device and an anchoring structure used to stabilizethe intracorporeal device in the body, such as in a vessel. Deliverysystems which deploy and secure the implant assembly in a desiredlocation in a vessel are also provided and generally include a deliveryapparatus and the implant assembly to be delivered. In certainimplementations, the intracorporeal device may be a pressure sensor,further described below. The anchoring structure may be a structurecapable of being introduced into the body via a delivery apparatus, suchas a catheter, and then lodged within the vessel. Anchoring structuresof this disclosure may include structure including opposed wire loops,radial wire array structures, and daisy petal structures, all furtherdescribed below.

All of the implant assemblies of this disclosure obstruct approximately50% or less of the cross-sectional area of the vessel in which they aredisposed. The implant assemblies may, in certain implementations,obstruct 20% or less of the cross-sectional area of the vessel.Minimizing the obstruction of flow within the vessel allows theintracorporeal device to remain secured in position in a vessel withoutcreating significant impact to the flow within the vessel. Furthermore,the implant assemblies disclosed herein generally rely on the physicalsize of the expanded anchoring structure coupled with the stiffness ofthe wire used to construct the anchoring structure to prevent furtherdistal movement. This is contrary to stent or vena cava filter typemechanisms wherein fixation is achieved by radially exerted force and/orhook or barb attachment features.

Anchoring structures of this disclosure may be formed from metal orpolymer and may be in the form of a wire structure. The wire diameter ofthe anchoring structures of the current disclosure lies in the range ofabout 0.001 to about 0.015 inches. The material comprising the wire canbe any biocompatible material known in the art that possess sufficientelastic properties to be useful for the purpose at hand. In oneimplementation the material comprising the wire is a polymer. In analternative implementation the material comprising the wire may be ametal, such as nitinol, stainless steel, eligiloy, cobalt chrome alloys,or any other suitable metal. In a further implementation, if the wire iscomprised of a metal material, the biocompatible wire is coated with adielectric material, such as, but not limited to, PTFE, polyurethane,parylene and diamond-like carbon (DLC) so as not to pose electromagneticinterference with the function of the intracorporeal device when thedevice comprises an RF sensor. The term “wire” used throughout thisdocument should be construed, without limitation, to embody the entirecontents of this paragraph.

The phrase “intracorporeal device” as used in this document includesany, and all, implantable devices. Such devices can include, e.g.,sensors that measure chemical and/or physical parameters, devicesconfigured to perform a function, e.g. drug delivery devices, andcombinations of the same. The intracorporeal device may communicate withexternal electronics either wirelessly or by being placed in physicalcontact with said electronics, such as by a wire.

The exemplary device disclosed herein describes a coating as a feature.It should be understood that this disclosure encompasses anintracorporeal device constructed of a polymeric material and that thesame construction techniques used to create the anchoring structurescould be employed by threading the wires directly through the polymericmaterial of the device. Additionally, materials used in the constructionof such intracorporeal devices, coatings or otherwise, could be anybiocompatible polymer. Such materials include but are not limited tobiocompatible silicone rubber, FEP, PTFE, urethane, PVC, nylon, andpolyethylene.

The intracorporeal device used to couple to the anchoring structuresdescribed below has a width of about 0.5 to about 4 mm, a height ofabout 0.5 to about 4 mm, and a length of about 0.5 to about 12 mm. Inone implementation, the intracorporeal device has a width ofapproximately 3.2 mm, a height of approximately 2 mm, and a length ofapproximately 10 mm. Examples of such devices are disclosed in commonlyowned U.S. Pat. Nos. 6,855,115; 7,147,604; 7,481,771; 7,574,792;7,699,059; and 9,265,428, each of which are incorporated herein byreference.

A. Wire Loop Structures

One example implant assembly adapted for deployment and fixation withina vessel includes an intracorporeal device and a wire structure havingwire loops. The loops may traverse the length of the device or may belimited to one end of the device. As shown in FIGS. 1 and 2 , oneimplementation of an implant assembly 30 having a double loop structure32 includes a wire 34 attached to an intracorporeal device 36 at anattachment site (not shown). The wire 34 is threaded through an end ofthe intracorporeal device 36 at a hole 38. The anchor point is formed bycrimping a piece of metal to the wire and trimming off the excess wire,so that the crimped-on metal comprises the terminal end of the wire.This metal end also provides a radiopaque marker for fluoroscopicvisualization of the device.

After the wire 34 is threaded through the hole 38 on one end of thedevice, the wire is pulled with sufficient force to bury the anchorfixedly into the coating of the intracorporeal device. The wire 34 isthen looped around to form the double loop configuration 32. The secondfree end is also inserted under the coating and the anchor is buried inthe coating to fix the anchor. In this manner, the ends of the wire areinserted under the coating of the intracorporeal device 36.

FIG. 3 illustrates the deployment of the implant assembly 30 within anarrowing vessel. The arrow 39 shown in FIG. 3 indicates the directionof blood flow. After being released into the vessel, the wire loop 34will contact the inner surface 40 of the wall of the vessel 42.Depending upon the configuration of the implant assembly 30 and theinner diameter of the vessel 42, this contact may occur immediately upondeployment. Alternatively, the implant assembly can be configured sothat the wire 34 of the implant assembly 30 does not initially contactthe inner surface 40 of the vessel 42 but instead travels down thenarrowing vessel until, at some point, the vessel narrows to such anextent that the wire loop 34 makes contact with the inner surface 40 ofthe vessel 42. Depending upon the compliance of the vasculature and thewire loop 34 of the implant assembly 30, the wire structure may compressradially inward or bow backwards as an interference fit is created. Or,depending upon the compliance of the wire comprising the implantassembly, the anchor structure 42 may yield, permitting the implantassembly 30 to travel further downstream. The implant assembly 30 willultimately reach a point in the narrowing vessel 42 at which aninterference fit between the wire loop 34 and the vessel will cause theimplant assembly to lodge and to be held in place against any furthermovement.

An alternate method of anchoring an implant assembly 30 is based uponthe principle of causing the intracorporeal device to lodge at afurcation in a vessel of a patient. As an example, the pulmonary artery,which originates in the right ventricle, divides into the right and leftpulmonary artery branches, one directed to each lung. These arteriesdivide and then subdivide, eventually to send arteries to all of thebronchopulmonary segments that form the different lobes of each lung.The pulmonary arterial vessels decrease in diameter significantly eachtime they divide.

The theory underlying the alternate method of anchoring an implantassembly is that the implant assembly, including the wire loops, cantravel down a first vessel with the flow of blood, but when the implantassembly reaches a furcation, the implant assembly is too large to fitthrough either of the smaller branch vessels. The implant assembly thuslodges at the furcation, prevented from moving downstream by being toolarge and not sufficiently compliant to fit into the branch vessels, andprevented from moving upstream by the flow of blood through thearteries. In one implementation, the implant assembly diameter is equalto or greater than the inner diameter of the first vessel. In this case,the implant assembly is sufficiently compliant so it does not produce aninterference fit as it travels down the vessel but does preserve theintended orientation of the implant assembly when it reaches thesubsequent furcation. In an alternate implementation, the implantassembly diameter is less than the inner diameter of the arterial vesselsuch that no particular orientation is actively preserved but theimplant assembly is too large and stiff to fit through subsequent branchvessels.

In either case, the implant assembly is configured such that, after ashort period of time, e.g. 30 days, the deployment position is furtherreinforced by tissue overgrowth of the wire loops where they contact thevessel wall. At this point, the dominant fixation mechanism is thetissue to wire connection and the implant assembly cannot be easilyremoved without risk of damaging the vessel.

Referring to FIG. 4 , the implant assembly 30 has been released into afirst vessel 49. The implant assembly is free to travel through thefirst vessel 49 with the flow of blood in the direction indicated by thearrows 51. At a furcation 53, the first vessel 49 divides into smallervessels 55, 56. Because the implant assembly 30 is substantially largerthan the cross-section of any of the smaller vessels 55, 56, the implantassembly cannot proceed any further and lodges at the furcation 53.

Referring now to FIG. 5 , a loop structure having a “figure eight” shapeis illustrated. More specifically, an implant assembly 31 having adouble loop structure 33 includes a wire 35 attached to theintracorporeal device body 37 at an attachment site (not shown). Theends of the wire 35 are inserted under the coating of the intracorporealdevice body 37 as described in the previous example.

The purpose of the “figure eight” or double loop structure 33 is tostabilize the intracorporeal device body from rotating or tumblingend-over-end within the vessel, thereby assuring that, in the case of awireless sensing element comprising the intracorporeal device, acoupling element of the intracorporeal device body remains properlyoriented with respect to optimal angles of interrogation viaextracorporeal communication and data acquisition devices. The “figureeight” or double loop structure 33 of the disclosed implementation maybe approximately 5 cm in length. However, it will be appreciated thatthe dimensions depend upon the inner diameter of the vessel into whichit is being placed within relatively wide tolerances, and that thedimensions of the “figure eight” or double-loop structure 33 can bemodified to adapt the device to any particular vessel. According to oneaspect of the disclosure, the overall length of the intracorporealdevice body plus double-loop structure 33 is at least two times, and, incertain implementations, at least about five times, the diameter of thevessel.

Referring to FIG. 6 , upon deployment of the implant assembly 31according to a first method, the implant assembly 31 is anchored by aninterference fit between the wire 35 and the inner surface 41 of thewall of the vessel 43. The arrow 51 indicates the direction of bloodflow.

FIG. 7 illustrates an alternate method of anchoring the implant assembly31, in which the implant assembly 31 is deployed, e.g., into a firstpulmonary arterial vessel 49 having a cross-section on the order of thecross-section of the implant 10 assembly. The implant assembly thustravels through the first vessel 49 in the direction of blood flow,indicated by the arrows 51. At a furcation 53, the first vessel 49divides into smaller vessels 55, 56. Because the cross-section of theimplant assembly 31 is substantially larger than the cross-section ofeither of the smaller vessels 55, 56, and not sufficiently compliant todeform further the implant assembly lodges at the furcation 53.

In the illustrated example, the opposed loop structure 33 of the implantassembly 31 is constructed of a single wire. However, it will beunderstood that the opposed loop structure 33 can be constructed of morethan one wire.

In alternative implementations shown in FIGS. 8, 9, 12, and 13 , thestructure includes a plurality of wire loops 44 encircling anintracorporeal device 46. The wire 48 is threaded from end to end in acircular fashion, through one or more holes 50 located on each end ofthe intracorporeal device, to form the loops. Upon completion of theloop structure, the free end of the wire is used to create anotheranchor as described above. The second free end is then pulled back intothe coating with sufficient force to bury the second anchor fixedly inthe coating. In one implementation, the location of the second anchorlies on the opposite side of the intracorporeal device from the firstanchor. This configuration is useful in order to position anchors awayfrom a sensing or actuating element and/or to provide a means fordetermining the orientation of the device when viewed via fluoroscopicmeans. The wire loops are then arranged by mechanical means to createwire members that are substantially evenly distributed radially aroundthe longitudinal axis of the intracorporeal device.

The wire loops may be attached to the intracorporeal device 40 bythreading through one hole 50 located near the edge of the device 46 asreferenced to the longitudinal axis of the device 46, as shown in FIG. 8. Alternatively, the wire loops may be attached to the intracorporealdevice 46 by threading through multiple holes 50 located near each edgeof the device 46, as shown in FIG. 12 .

The implant assemblies of FIGS. 8, 9, 12, and 13 may be deployedaccording to either of the two methods described above. The implantassemblies can be configured so that they are anchored by aninterference fit between the implant assemblies and the walls 52 of thevessel 54, as shown in FIGS. 10 and 14 and described previously. Or theimplant assemblies can be configured so that they are allowed to traveldown a vessel and lodge at a furcation as previously described. Thearrows 51 shown in FIGS. 10, 11, 14, and 15 indicate the direction ofblood flow.

Referring now to FIGS. 35-37 , an implant assembly 130 includes anintracorporeal device 131, an elongated “figure eight” wire loop 132,and a pair of wing-like wire loops 134. The wing-like wire loops 134have a longest dimension in a plane orthogonal to the longitudinal axisof the vessel. This longest dimension is, within wide tolerances, on theorder of the vessel inner diameter into which the implant assembly 130is to be introduced, so as to permit the implant assembly to travel downthe blood stream until it lodges at a furcation. The “figure eight” wireloop 132 has a length which is greater than the diameter of the vesselinto which the implant assembly 130 is to be introduced so as to preventthe implant assembly from flipping end-to-end within the vessel. Thelength of the “figure eight” wire loop 132 may be at least twice thediameter of the vessel into which the implant assembly 130 is to beintroduced, and the length of the “figure eight” wire loop 132 may beapproximately five times the diameter of the vessel. This feature isuseful to maintain a desired orientation of the implant assembly 130with respect to the fluid flow within the vessel. In certainimplementations, the “figure eight” wire loop lies in a plane, and thewing-like wire loops are oriented substantially perpendicular to theplane defined by the wire loops.

B. Radial Wire Array Structures

Another implant assembly according to this disclosure includes anintracorporeal device and an anchoring structure having a substantiallyparabolic-shaped profile, as shown in FIGS. 16-18 . As illustrated, animplant assembly 58 includes an intracorporeal device 60 and a radialwire array 62, which includes wire members 64. Members 62 may beattached to the intracorporeal device 60 at an anchor point, asdescribed below.

The radial wire array 62 can be attached to the intracorporeal device 60by threading the wire members 64 through one hole 66 located near theedge of the intracorporeal device 60, as shown in FIG. 16 .Alternatively, the radial wire array 62 can be attached to theintracorporeal device 60 by threading the wire members 64 through twoholes 66 located near the edge of the device 60 as shown in FIG. 20 .The wire end is press-fit into a coating covering the surface of thedevice to secure the end. The radial wire array may be formed bycrimping a piece of metal at a point substantially midlength of the wirebundle and then threading the wire bundle through a hole near the edgeof the intracorporeal device, thus lodging the anchor within thesilicone material filling the hole. The anchor secures the end of theradial wire between the surface of the device and the coating coveringthe surface of the device. The crimped metal anchor provides aradiopaque marker for fluoroscopic visualization of the device.

Upon deployment of the implant assembly, the implant assembly can beanchored either by an interference fit between the radial wires and thewalls of the vessel, as shown in FIG. 21 , or by traveling within avessel until the implant assembly lodges at a furcation, as shown inFIG. 22 .

In one implementation, the radial wire array is self-supporting, as aresult of the physical properties of the material. Alternatively, theradial wire array may include a mechanical expansion structure tosupport the array to expand and contact the vessel wall. For example, acatheter balloon may be inflated to cause a wire structure to attain andmaintain an expanded configuration.

The intracorporeal device 60 can be positioned outside a radial wirearray 62 so that one end 72 of the intracorporeal device 60 is fixed toa point at or near the apex of the radial wire array 62, as shown inFIG. 16 . The intracorporeal device 60 can also be positioned inside theradial wire array so that one end of the device is fixed to a point ator near the apex of the radial wire array, as shown in FIG. 17 . Inanother implementation, the intracorporeal device may have two radialwire arrays 62 attached to the intracorporeal device 60 so that one endof the intracorporeal device is attached to the apex on the exterior ofone of the radial wire arrays and the opposing end of said device isattached to the apex on the interior of the second radial wire array, asshown in FIG. 18 .

C. Daisy Petal Structures

An implant assembly according to another aspect of this disclosureincludes an intracorporeal device and an anchoring structure having adaisy petal shape, as shown in FIGS. 19-22 . The implant assembly 76includes an intracorporeal device 78 and a daisy petal wire structure80, which contacts the inner surface 82 of the wall of the vessel 84, asshown in FIG. 23 . The implant assembly of this implementation can beanchored by an interference fit between the implant assembly and thewalls of the vessel. In the alternative, the implant assembly can beconfigured, within wide tolerances, to have a diameter on the order ofthe vessel inner diameter into which the implant assembly 130 is to beintroduced, so as to permit the implant assembly to travel down theblood stream until it lodges at a furcation, as shown in FIG. 24 . Thearrows 51 shown in FIGS. 23 and 24 indicate the direction of blood flow.

The daisy petal wire structure 80 is positioned so that the structurelies in a plane normal to a longitudinal axis of the intracorporealdevice 78. The daisy petal wire structure 80 may be constructed of asingle wire or of a plurality of wires. As shown in FIG. 19 , the daisypetal wire structure 80 includes a plurality of lobes 92. The structuremay have either an even or an odd number of lobes. As shown in FIG. 20 ,the intracorporeal device 78 may have two daisy petal wire structures 80attached to the device on opposing ends 94, 96 and located along thelongitudinal axis 90.

The daisy petal wire structure 80 may be attached to the intracorporealdevice 78 by threading through a single hole 98 located near the edge ofthe device 78, as shown in FIG. 21 . Alternatively, the daisy petal wirestructure 80 may be attached to the intracorporeal device 78 bythreading through two holes 98 located near the edge of the device 78,as shown in FIGS. 19 and 22 .

In one implementation, the daisy petal wire structure 80 is attached tothe intracorporeal device at an anchor point. The anchor is made bycrimping a piece of metal to the wire and trimming off the excess wire,so that the crimped-on metal comprises the terminal end of the wire.This metal end also provides a radiopaque marker for fluoroscopicvisualization of the device. The wire is threaded through the hole orholes on one end of the intracorporeal device and the wire is pulledwith sufficient force to bury the anchor fixedly into the coating. Thewire is then threaded from top to bottom in a circular fashion, throughthe hole or holes located on the end of the intracorporeal device, toform the daisy petal structure. Upon completion of the daisy petalstructure, the free end of the wire is used to create another anchor.The second free end is then pulled back into the coating with sufficientforce to bury the second anchor fixedly in the coating. The wire loopsare then arranged by mechanical means to create wire members that aresubstantially evenly distributed radially around the longitudinal axisof the intracorporeal device.

D. Delivery Systems and Methods

This disclosure further provides a delivery system for securing,delivering, and deploying an implant assembly having an anchoringmechanism coupled to an intracorporeal device. Referring to FIGS. 25-29, the various components of the delivery system are shown individually.As shown in FIG. 25 , the delivery apparatus 100 includes a main lumen102 adapted to accept a core wire 104 (FIG. 27 ) and a secondary lumencomprising a first section 106A and a second section 106B and adapted toaccept a tether wire 108 (FIG. 26 ). The core wire 104, shown in FIG. 27, provides columnar stiffness to the delivery assembly 100, therebyfacilitating advancement of the delivery assembly through thevasculature. Additionally, the core wire 104 also prevents buckling ofthe delivery assembly 100 when the tether wire is pulled proximallyduring the implant assembly deployment. The core wire 104 has adecreasing diameter toward its distal end 105, providing gradualdecrease in stiffness from the proximal to the distal end of thedelivery assembly 100. The tapered core wire 104 can extend past aguidewire aperture 112 in order to reinforce a potential kink point inthe delivery apparatus 100 and to facilitate the advancement of theguidewire into the vasculature. The core wire 104 is fixed in the mainlumen 102 using adhesive, thermocompression, or any other suitablefixation mechanism. Fixation of the core wire 104 prevents the core wirefrom being disturbed by the guidewire 110, shown in FIG. 28 , when theguidewire 110 enters the main lumen 102 of the delivery apparatus 100 atthe guidewire aperture 112 as shown in FIG. 33 .

The tether wire 108, shown in FIG. 26 , is slidably positioned withinthe first secondary lumen portion 106A and exits the first secondarylumen portion at an aperture 114 in the wall of the device. As shown inFIG. 29 , the tether wire 108 then passes through the coating of theintracorporeal device 30, exiting on the opposite side of the device.The free end 118 of the tether wire 108 enters the second portion 106Bof the secondary lumen at the aperture 109.

FIG. 30 shows an alternate implementation of a delivery apparatusadapted to deploy intracorporeal devices, such as the intracorporealdevice 31 of FIGS. 5-7 . Because of the length of the wire loops 35 ofthe intracorporeal device 31, the proximal and distal ends of the loopsmust be secured to the delivery apparatus so that, when the deliveryapparatus curves, the loops will follow the curvature of the deliveryapparatus. Toward that end, the secondary lumen of the deliveryapparatus of FIG. 30 is divided into four sections 124A-D. The tetherwire 108 exits the first section 124A of the secondary lumen and passesover and through wire loops 55 to attach the implant assembly 51 to thedelivery apparatus 100. The tether wire then enters the second portion124B of the secondary lumen. The tether wire then exits the secondportion 124B of the secondary lumen and passes through the coating ofthe intracorporeal device 31. The tether wire then enters the thirdportion 124C of the secondary lumen. Next, the tether wire exits thethird portion 124C of the secondary lumen, passes over the wire loop 35,and enters the fourth section 124D of the secondary lumen.

In yet another configuration, an outer sleeve may be provided toconstrain an expansible structure and is slidably positioned over thedouble lumen tube.

Deployment and fixation of an implant assembly may be accomplishedpassively by either an interference fit or lodging at a furcation. Inone implementation, an implant assembly, including an anchoringstructure of sufficient size and/or compliance, is delivered into thevessel and allowed to travel in the blood stream until it lodges at afurcation. After lodging in the vessel, blood flow is maintained due tothe configuration of the implant assembly. In another implementation, animplant assembly includes an anchoring structure of sufficientcompliance that, upon narrowing of the vessel, produces an interferencefit thereby preventing substantially any further progress of the devicedown the vessel. In a third implementation, the intracorporeal deviceembolizes without an anchor structure. It could be preferable toeliminate the need for a securing device and to allow the intracorporealdevice to reside in a vessel that is small enough to prevent furthermovement of the intracorporeal device. As an illustration, it issuspected that the small size of the intracorporeal device would have nodeleterious effect on lung function due to the redundancy of blood flowin the lungs at the small vessel level.

One method of deploying and fixing an implant assembly according to thisdisclosure is described below. Access is gained into the vasculature anda vessel introducer is positioned in the access site. The access sitefor the vessel introducer may be the right internal jugular vein, thesubclavian artery, the right femoral vein, or any other suitable accesssite. A guidewire is placed in the vasculature and positioned across thedesired deployment site with the aid of, e.g., a Swan-Ganz catheter, adiagnostic catheter or any other suitable catheter, such catheter beingremoved after the guidewire is in position.

The delivery system is loaded into the vessel introducer and navigatedto the deployment site. The delivery system length can be increased ordecreased according to standard practice depending on the access sitechosen. In one implementation, the deployment site is a vessel, and maybe any artery or arteriole in the pulmonary artery vasculature.Optionally, the implant assembly is oriented to a preferred orientation.Then, the implant assembly is deployed by pulling the tether wireproximally to disengage the implant assembly from the deliveryapparatus. Upon deployment, the implant assembly is allowed to travel inthe vasculature until an interference fit is produced or it lodges atthe next furcation in the vasculature, depending on which mode offixation is intended. The delivery assembly and guidewire are thenremoved from the body.

In an alternative implementation of this method, an outer sleeve isprovided to constrain an expansible anchor structure so that sliding theouter sleeve proximally allows expansion of the expansible anchorstructure. The anchor structure is allowed to expand and the implantassembly travels down the vessel until an interference fit is producedor it lodges at the next furcation in the vasculature, depending onwhich mode of fixation is intended. The delivery assembly and guidewireare then removed from the body.

For the purpose of illustration, the pulmonary artery is selected as thedeployment site for an intracorporeal device. In this example,considerations relevant to the placement of a pressure sensor aredisclosed. Other intracorporeal devices could be positioned in alternatelocations via modifications to the examples disclosed in this document,such locations and methods being obvious to one skilled in the art inlight of the disclosure provided herein. To deploy an implant assemblyinto a pulmonary arterial vessel, the right femoral vein is chosen asthe access site. The user gains access to the femoral vein viatranscutaneous puncture or cut-down. A vessel introducer is placed inthe site. A Swan-Ganz or guiding catheter is maneuvered into thepulmonary artery. The path to the pulmonary artery is as follows: thefemoral vein leads to the inferior vena cava. From the inferior venacava, the catheter travels through the right atrium to the rightventricle and, finally, to the pulmonary artery. At this point, theright or left branch of the pulmonary artery is selected, and theSwan-Ganz or guiding catheter is positioned in the descending branch ofeither the right or left pulmonary artery. A guidewire is placed at thedeployment site, and the Swan-Ganz or guiding catheter is removed. Atthis point, the delivery catheter is loaded over the proximal end of theguidewire. Optionally, a guiding catheter can be loaded over theproximal ends of the guidewire and delivery catheter to a point wherethe distal end of this guiding catheter is located immediately proximalto the implant assembly on the delivery catheter. The delivery catheter(and, optionally, guiding catheter) is tracked over the guidewire to thedeployment site. The tether is pulled proximally to disengage theimplant assembly from the delivery apparatus.

The lung can be divided into three zones depending on the relationshipbetween the pulmonary artery pressure, alveolar pressure, and pulmonaryvenous pressure. In Zone 1, the uppermost portion of the lung, thealveolar pressure is greater than that of either the pulmonary artery orthe pulmonary vein, causing collapse of the vessel during eachrespiratory cycle. (Zone 1 conditions do not normally occur in humans.)In Zone 2, the alveolar pressure is less than the pulmonary arterypressure and greater than the pulmonary venous pressure leading to astate of partial vessel collapse. However, in Zone 3, at the bottom ofthe lungs, all blood vessels remain fully open during the entirerespiratory cycle because of the fact that both the pulmonary artery andvenous pressures are greater than the alveolar pressure. The implantassembly is released into the descending branch of either the right orleft pulmonary artery because this will cause the intracorporeal deviceto lodge in Zone 3 of the lungs. It is not known whether vessel collapsewould cause any deleterious effect on the pressure measured by thesensor, but devices in accordance with the present disclosure eliminatethis unknown by positioning the sensor in a location where thepossibility of this phenomenon is minimized.

E. Delivery Systems Including External Sheaths

As previously discussed, the general process for implantingintracorporeal devices, such as those described herein, includesidentifying a deployment site for the device and gaining access tovasculature corresponding to the deployment site, such as by atranscutaneous puncture or cut-down. A Swan-Ganz or similar guidingcatheter may then be inserted through the access point and delivered tothe deployment site. A guidewire, such as the guidewire 110 illustratedin FIGS. 28-29 may then be inserted through the guiding catheter to thedeployment site. Once the guidewire is properly placed, the guidingcatheter may be removed and a proximal end of the guidewire may beinserted into a delivery catheter of a delivery apparatus, such asillustrated in FIGS. 29-30 . The delivery catheter, which is coupled tothe intracorporeal device to be implanted, may then be translated alongthe guidewire such that the intracorporeal device is delivered to theimplantation location. Once properly positioned, the intracorporealdevice may be deployed as previously described in this disclosure, suchas by withdrawing a tether wire that couples the intracorporeal deviceto the delivery catheter.

In implementations according to this disclosure, an additional sheath orcatheter may be disposed about each of the delivery catheter and theguidewire. Such a sheath provides various benefits. For example, andwithout limitation, the sheath may provide additional protection duringinsertion of the delivery catheter. The sheath may also provide multiplelumens that may be used to inject contrast media or obtain pressuremeasurements. A lumen of the sheath may also be used to direct othertools to adjust, reposition, or rewire the intracorporeal device duringthe deployment process. In certain implementations, the sheath may alsobe used to provide a proximal “stop” for the intracorporeal device toreduce the likelihood of migration of the intracorporeal device duringdeployment.

Referring to FIG. 31 , a delivery system 300 for delivery of anintracorporeal device 30 is provided. In general, the system 300includes the system 100 illustrated in FIGS. 25-29 disposed within asheath 302 that extends over a substantial length of each of thedelivery catheter 303 and the guidewire 110. Accordingly, unlessotherwise indicated, the previous discussion regarding the deliverysystem of FIGS. 25-29 and its components are applicable to the followingdescription.

As illustrated in FIG. 31 , in certain implementations the sheath 302may define multiple, separate lumens such as a delivery catheter lumen304 and a guidewire lumen 306. In other implementations, the sheath 302may instead include a single lumen through which both of the deliverycatheter 303 and the guidewire 110 pass. In still other implementations,the sheath 302 may define more than two lumens to facilitate theinsertion of additional tools or to otherwise provide additionalchannels between a hub of the delivery system (described below in moredetail in the context of FIG. 32 ) and the deployment location.

In addition to facilitating delivery of the intracorporeal device 30,the lumens of the sheath 302 may also be used to provide otherfunctionality. For example, and without limitation, one or more lumensof the sheath 302 may be used to inject fluids, such as contrast media,adjacent the deployment location of the intracorporeal device 30 toenable more accurate monitoring of the delivery process usingfluoroscopy or similar methods. One or more lumens of the sheath 302 mayalso be used as conduits from which pressure measurements may beobtained. Regardless of the additional functionality to be provided,lumens of the sheath 302 for providing such functionality must generallyhave a sufficient cross-sectional area to allow fluid communicationbetween the deployment site and a hub 310 (shown in FIG. 32 anddiscussed below in more detail) of the delivery system 300. So, forexample, a lumen for providing additional functionality may be separateand independent of any lumen containing the delivery catheter 303 and/orthe guidewire 110. Alternatively, if a lumen contains one, or both, ofthe delivery catheter 303 and the guidewire 110, the lumen may beoversized such that excess cross-sectional area is provided for theadditional functionality. For example, the delivery catheter lumen 304may have a cross-sectional area greater than that of the deliverycatheter 303 such that an annular volume 307 is defined between thedelivery catheter 303 and the wall defining the delivery catheter lumen304. The hub 310 may then include a port or similar access point influid communication with the annular volume 307 to permit injection orremoval of fluid, insertion of tools, measurement using various gauges,or other similar functionality requiring a path between the exterior ofthe hub and the deployment location.

For purposes of this disclosure, a lumen for providing functionalityother than receiving the delivery catheter and/or the guidewire isreferred to as an “auxiliary lumen”. Accordingly, an auxiliary lumen maycorrespond to a lumen that is separate and distinct from the deliverycatheter lumen and the guidewire lumen or may refer to the deliverycatheter lumen and/or the guidewire lumen when the delivery catheterlumen and/or the guidewire lumen are over-sized to accommodate both thedelivery shaft/guidewire and any additional volume required forperforming the additional functionality.

Examples of sheaths in accordance with the present disclosure areillustrated in FIGS. 33-34 , which each illustrate cross-sections ofsheaths 302 in accordance with the present disclosure. As shown, each ofthe sheaths 302 illustrated in FIGS. 33-34 include a delivery catheterlumen 304 and a guidewire lumen 306. In the implementation of FIG. 33 ,each of the delivery catheter lumen 304 and the guidewire lumen 306 aresubstantially semi-circular in shape. In contrast, the sheath 302 ofFIG. 34 includes a crescent-shaped delivery catheter lumen 304 and acircular guidewire lumen 306. Although each of FIGS. 33 and 34 includetwo separate lumens, sheaths in accordance with the present disclosuremay include one or more lumens. Also, while each of the lumens of thesheaths are intended to receive one of the delivery catheter 303 and theguidewire 110, the delivery catheter 303 and the guidewire 110 may sharea single lumen. Moreover, the sheath 302 may include multiple lumenswithin which neither of the delivery catheter 303 and the guidewire 110is disposed. Such auxiliary lumens may be used to facilitate delivery ofother wires, catheters, tools, and the like, or may provide additionalfluid pathways through the delivery system 300.

The sheath 302 may be formed from various materials including one ormore of biocompatible polymers and metals. For example, in certainimplementations, the sheath 302 may be formed from an extruded polymer.In other implementations, the sheath 302 may include polymer or metallicstructures embedded within a polymer matrix. For example, a braided wireformed of a biocompatible metal (such as nitinol or stainless steel) maybe embedded within a matrix of nylon, Pebax, or other, biocompatiblepolymer. Sheaths in accordance with this disclosure may also include oneor both of an inner and outer liner layer that may also be formed from abiocompatible polymer or metal. The particular size of the sheath 302may vary depending on the particular application for which it is used.For example, and without limitation, in one implementation, the sheathmay have a size of 5 Fr. One or more radiopaque markers may also bedisposed on, embedded within, or otherwise coupled to the sheath 302 andused in conjunction with a fluoroscopy or similar machine to provideincreased visibility of the sheath 302 during the implantation.

FIG. 35 illustrates the sheath 302 of FIG. 34 with the delivery catheter303 and the guidewire 110 disposed within the delivery catheter lumen304 and the guidewire lumen 306, respectively. As illustrated, thedelivery catheter lumen 304 has a cross-section that is substantiallylarger than that of the delivery catheter 303. Accordingly, an annularvolume 307 is defined between the delivery catheter 303 and an innerwall of the delivery catheter lumen 304. The annular volume 307 may beused for, among other things, injecting or extracting fluids (such ascontrast media) to or from the deployment location; enabling delivery ofadditional wires, catheters, tools, or the like to the deploymentlocation; or establishing a tap that may be used to measure pressure orother parameters at the deployment location.

FIG. 32 is a side elevation view of a hub 310 of a delivery system 300in accordance with the present disclosure. As illustrated, the hub 310includes each of a distal hub portion 312 and a proximal hub portion 314which are separable from each other. However, in other implementations,each of the distal hub portion 312 and the proximal hub portion 314 maybe integrated into a unitary structure.

As illustrated in FIG. 32 , the distal hub portion 312 includes a distalhub body 316 from which the sheath 302 distally extends. The distal hubportion 312 may further include one or more ports, such as port 318, tofacilitate various functions. For example, in certain implementationsthe port 318 may be adapted to enable flushing of the distal hub portion312. The port 318 may also be adapted to allow injection of contrastmedia or other fluids for delivery to the deployment location of theintracorporeal device. In other cases, the port 318 may be in fluidcommunication with the deployment location via one or more lumens of thesheath 302 such that a pressure gauge or similar pressure measurementdevice may be coupled to the port 318 to measure pressure in thedeployment location. In still other cases, the port 318 may be used toinsert wires, catheters, tools, or other items for delivery to thedeployment location via the sheath 302. As illustrated, the distal hubportion 312 further includes a distal seal 320 and a proximal seal 322.For example, and without limitation, each of the distal seal 320 and theproximal seal 322 may be Tuohy-Borst-type adapters that prevent backflowabout instruments inserted therethrough.

As further illustrated in FIG. 32 , the proximal hub portion 314includes a proximal hub body 324 including a first branch 325A forreceiving the guide wire 110 and a second branch 325B through which thedelivery catheter is inserted. The proximal hub body 324 may furtherinclude one or more caps or seals, such as guidewire cap 326 andproximal seal 328.

The method of implementing the hub 310 of FIG. 32 is generally asfollows. The intracorporeal device 30 is loaded onto the deliverycatheter 303 as previously described in the context of FIGS. 25-30 . Theloaded delivery catheter 303 is then inserted through the sheath 302 andeach of the distal hub portion 312 and the proximal hub portion 314. Inimplementations in which the sheath 302 includes a delivery catheterlumen 304, insertion of the loaded delivery catheter 303 generallyincludes passing a proximal end of the delivery catheter 303 into andthrough the delivery catheter lumen 304.

With respect to the patient, an access point is formed, such as by atranscutaneous puncture or cut-down, and a Swan-Ganz or similar guidingcatheter is inserted through the access point of the patient anddelivered to the deployment site. The guidewire 110 is then insertedthrough the guiding catheter such that a distal end of the guidewire 110is delivered to the deployment site for the intracorporeal device 30.Once the guidewire 110 is properly located, the guiding catheter isremoved. Notably, the process of loading the delivery catheter 303 anddelivery of the guidewire 110 are separate processes that may occur inany order.

The delivery catheter 303 and hub 310 are then loaded onto the guidewire110. In general, this process involves inserting a proximal end of theguidewire 110 into a lumen of the sheath 302 (such as the guidewirelumen 306) and passing the delivery catheter 303 and the hub 310 alongthe guidewire 110 such that a distal end of the delivery catheter 303 ispositioned at the deployment location for the intracorporeal device 30.Once so positioned, the intracorporeal device 30 is released from thedelivery catheter 303, such as by withdrawing a tether wire 108 couplingthe intracorporeal device 30 to the delivery catheter 303. Afterdeployment of the intracorporeal device 30, each of the deliverycatheter 303, the sheath 302, and the guidewire 110 may be extractedfrom the patient.

In implementations in which the intracorporeal device 30 is deployed bywithdrawing a tether wire 108, the tether wire 108 friction between theintracorporeal device 30 and the tether wire 108 may result in proximalshifting of the intracorporeal device 30 as the tether wire 108 iswithdrawn. To avoid such displacement, the sheath 302 may distallyextend such that a distal end of the sheath 302 is adjacent theintracorporeal device 30 when the intracorporeal device 30 is loadedonto the delivery catheter 303. Any proximal shifting of theintracorporeal device 30 would then result in the intracorporeal device30 abutting the sheath 302, thereby preventing proximal displacementduring deployment. Alternatively, the sheath 302 may be configured to betranslatable along the guidewire 110 such that prior to deployment ofthe intracorporeal device 30, the sheath 302 may be distally translatedto prevent proximal displacement of the intracorporeal device 30 duringdeployment.

F. Delivery Systems Including in-Line Delivery Shafts

Previously discussed implementations of the present disclosure generallyinclude an intracorporeal device that is releasably coupled to a distalportion of a delivery catheter. More specifically, the intracorporealdevices are coupled to the delivery catheters by disposing theintracorporeal device adjacent the distal portion of the deliverycatheter and then tethering the intracorporeal device to a side of thedelivery catheter using a tether wire. The assembly may be then loadedonto a guidewire by inserting a proximal end of the guidewire through alumen defined by the delivery catheter or a sheath through which thedelivery catheter extends.

While side-mounting the intracorporeal device to the delivery catheterenables delivery of the device to a deployment location within thevasculature of a patient, the side-mounted approach has certainlimitations. For example, the total width of the delivery system isnecessarily limited to no less than the total width of theintracorporeal device, the delivery catheter, and the guidewire. Thetether-based approach also requires that the delivery catheter extendsubstantially beyond the distal end of the intracorporeal device (asillustrated, for example, in FIGS. 29 and 30 ) to enable fixation of thedistal end of the tether to the delivery catheter. In practice, suchadditional length is generally on the order of 1.25 inches. Accordingly,deployment locations available using the side-mounted delivery methodcan be limited based on the various imposed dimensional limitations.

Using a tether, as in the previously discussed side-mounted approach,may also present certain issues related deployment accuracy of theintracorporeal device. For example, when withdrawing the tether from theintracorporeal device during deployment, friction between the tether andthe intracorporeal device may cause the intracorporeal device to bepulled proximally, shifting the intracorporeal device out of itsintended deployment position. Such displacement may also occur as aresult of withdrawing the delivery catheter after the intracorporealdevice has been released. For example, as the delivery catheter iswithdrawn, it may contact the intracorporeal device, knocking theintracorporeal device out of place or proximally pulling theintracorporeal device due to friction between the delivery catheter andthe intracorporeal device.

To address the foregoing issues, the present disclosure provides analternative delivery system for deployment of intracorporeal devices. Incontrast to the previously discussed side-mounted approach, thedisclosed delivery system instead allows the intracorporeal device to bereleasably coupled to a distal end of a shaft. For example, in oneimplementation, the delivery system includes a delivery shaft having athreaded tip that can be coupled with a corresponding female hole formedin a proximal end of the intracorporeal device. Accordingly, afterplacement of the intracorporeal device, the delivery shaft may becounter-rotated to unscrew the tip from the hole, thereby releasing theintracorporeal device. As a result, the intracorporeal device and thedelivery shaft are maintained in a substantially coaxial arrangementsuch that their overall width does not exceed that of the intracorporealdevice when the intracorporeal device is coupled to the delivery system.

In certain implementations, the overall width of the delivery system isfurther reduced by including a guidance feature on the intracorporealdevice that is shaped to receive the guidewire during delivery anddeployment. As a result, the guidewire is maintained in relatively closeproximity to the intracorporeal device as compared to side-mounteddelivery systems in which the guidewire is passed through a lumen of thedelivery catheter.

In addition to reducing the overall size of the delivery system ascompared to side-mounted configurations, certain implementations of theend-mounted delivery systems mitigate the potential for migration of theintracorporeal device during deployment. For example, in implementationsin which a threaded connection is used between the delivery catheter andthe intracorporeal device, deploying the intracorporeal device requiresrotation of the delivery catheter but does not generally requireproximal pulling of the delivery catheter that may cause movement of theintracorporeal device.

In light of the foregoing, the decreased size of end-mounted deliverysystems in accordance with the present disclosure increase the number ofpossible deployment locations for intracorporeal devices as compared toside-mounted configurations. Moreover, in certain implementations, theaccuracy of such deployments is also improved by reducing the amount ofproximal pulling of the delivery catheter that is required to deploy theintracorporeal device.

FIGS. 36-37 are side elevation views of a distal end 401 of a deliverysystem 400 in accordance with the present disclosure. FIG. 36illustrates the delivery system 400 including an intracorporeal device450 while FIG. 37 excludes the intracorporeal device 450 for clarity andto illustrate other aspects of the delivery system 400. Although theintracorporeal device 450 is illustrated as being wireless,implementations of the present disclosure may be used in conjunctionwith wired intracorporeal devices as well.

As illustrated, the delivery system 400 generally includes a sheath 402through which each a delivery shaft 404 is passed and within which aguidewire 406 may be received. More specifically, during an implantationoperation for the intracorporeal device 450, the guidewire 406 may beinserted into a patient such that the guidewire 406 extends from outsidethe patient to the desired deployment location for the intracorporealdevice 450. Accordingly, to deliver the intracorporeal device 450 to thedesired deployment location, the delivery system 400 is loaded onto aproximal end of the guidewire 406 and translated along the guidewire 406until the intracorporeal device 450 is properly located.

The sheath 402 may define one or more lumens. For example, asillustrated in FIGS. 36-37 , the sheath 402 includes each of a deliveryshaft lumen 407 and a guidewire lumen 408 shaped to receive the deliveryshaft 404 and the guidewire 406, respectively. The delivery shaft 404and the guidewire 406 may alternatively be received by the same lumen.Moreover, the sheath 402 may define additional lumens other than thoseused to receive the delivery shaft 404 and the guidewire 406.

In certain implementations, one or more lumens of the sheath 402 may beused to provide additional functionality other than or in addition toreceiving the delivery shaft 404 and the guidewire 406. For example, andwithout limitation, a lumen of the sheath 402 may be adapted to enableinjection of a contrast media or other fluid to the deployment location.As another example, the lumen may be adapted to enable extraction orsampling of fluid from the deployment location. As yet, another example,a pressure gauge or other sensor device may be coupled to the lumen tomonitor or measure physiological parameters, such as blood pressure, atthe deployment location. Such additional functionality may be achievedby providing additional lumens other than those adapted to receive thedelivery shaft 404 and the guidewire 406. Alternatively, the lumens forreceiving the delivery shaft 404 and/or the guidewire 406 may beoversized such that an annular volume about the delivery shaft 404and/or the guidewire 406 may be used to facilitate the additionalfunctionality.

Similar to the lumen 302, a lumen for providing additional functionalityother than receiving the delivery catheter and/or the guidewire isreferred to herein as an “auxillary lumen.” Accordingly, an auxiliarylumen may correspond to a lumen that is separate and distinct from thedelivery shaft lumen and the guidewire lumen or may refer to thedelivery shaft lumen and/or the guidewire lumen when the delivery shaftlumen and/or the guidewire lumen are over-sized to accommodate both thedelivery shaft/guidewire and any additional volume required forperforming the additional functionality.

In certain implementations, the sheath 402 may be substantially similarto the sheath 302 discussed in the context of FIGS. 31-35 . Accordingly,the foregoing discussion regarding the design of the sheath 302 isequally applicable to the sheath 402 of the delivery system 400.

The delivery shaft 404 includes a distal coupling feature 410 adapted toreleasably couple with a corresponding proximal coupling feature 452 ofthe intracorporeal device 450. In the implementation illustrated inFIGS. 36-37 , for example, the distal coupling feature 410 of thedelivery shaft 404 is a male threaded tip and the proximal couplingfeature 452 of the intracorporeal device 450 is a female threaded hole.Accordingly, the delivery shaft 404 is releasably coupled by screwingand unscrewing the distal coupling feature 410 into and out of theproximal coupling feature 452.

When coupled by the distal coupling feature 410 and the proximalcoupling feature 452, the delivery shaft 404 and the intracorporealdevice 450 are maintained in a substantially coaxial arrangement. Moregenerally, the delivery shaft 404 is maintained within the outer boundsof the intracorporeal device 450 such that, when coupled, the deliveryshaft 404 is located within an axial envelope 454 defined by a body 451of the intracorporeal device 450. Accordingly, the delivery shaft 404does not increase the total width of the delivery system 400 whencoupled to the intracorporeal device 450.

A threaded connection between the delivery shaft 404 and theintracorporeal device 450 is just one example of potential couplingfeatures that may be used to join the delivery shaft 404 and theintracorporeal device 450. Various other coupling mechanisms may beimplemented provided the delivery shaft 404 is maintained within theaxial envelope 454 defined by the body 451 of the intracorporeal device451 and the coupling of the delivery shaft 404 to the intracorporealdevice 450 is sufficiently robust to maintain the intracorporeal device450 on the delivery shaft 404. For example, in one alternativeimplementation, the distal coupling feature 410 and the proximalcoupling feature 452 may be coupled by a twist-lock mechanism. Inanother example implementation, the distal coupling feature 410 may beselectively expandable such that it may be expanded the proximalcoupling feature 452 to couple the delivery shaft 404 to theintracorporeal device 450. In yet another example implementation, thedistal coupling feature 410 may be magnetically coupled to the proximalcoupling feature 452. In such implementations, the delivery couplingfeature 410 may include an electromagnet that may be selectivelyactivated or deactivated to retain or release the intracorporeal device450, respectively. In still another implementation, the distal couplingfeature 410 may include a snare or hook shaped to engage and retain theproximal coupling feature 452 such that by extending or expanding thesnare or hook, the delivery shaft 404 and the intracorporeal device 405may be selectively coupled and decoupled.

The term “delivery shaft”, as used herein, is intended to refergenerally to a flexible elongate body with a distal end that isreleasably coupleable to the proximal end of the intracorporeal device450. In certain implementations, the delivery shaft may be formed from asingle wire or strand or may include multiple wires or strands wound orotherwise coupled into a cable. The delivery shaft may be formed fromone or more biocompatible materials including, without limitation, oneor more of biocompatible polymers (e.g., polyether ether ketone (PEEK),polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE),polystyrene (PS), nylon, polyethylene terephthalate (PET), polyimide(PA), polycarbonate (PC), acrylonitrile butadiene (ABS), or polyurethane(PU)) or metals (e.g., stainless steel, titanium, steel alloys, andtitanium alloys, such as Nitinol). In certain implementations, thedelivery shaft may include multiple materials elements. For example, theshaft may include a reinforced braid made of a relatively hard metal orpolymer embedded within a relatively flexible polymer body.

As illustrated in FIG. 36 , the intracorporeal device 450 may include aguide 456 adapted to receive the guidewire 406. The guide 456 generallyprovides a passage 458 or channel through which the guidewire 406 mayextend. In the illustrated implementation, for example, the guide 456 isdisposed on a side of the intracorporeal device 450 near the distal endof the intracorporeal device 450. As a result, the guide 456 extendsfrom a bottom side 455 of the intracorporeal device 450 such that thepassage 458 is offset from the body 451 of the intracorporeal device450. In other implementations, the guide 456 may alternatively becoupled to a top surface, a side surface, a proximal surface, or adistal surface of the intracorporeal device 450 provided the passage 458is sufficiently offset from the body 451 of the intracorporeal device(e.g., positioned outside the axial envelope 454).

FIG. 38 is a side elevation view of a proximal end 403 of the deliverysystem 400. The proximal end 403 generally includes a hub 430 adapted toreceive and manipulate each of the guidewire 406 and the delivery shaft404. The sheath 402 of the delivery system 400 is coupled to and extendsfrom a distal end of the hub 430. The hub 430 further includes each of aguidewire passage 432 and a delivery shaft passage 434 shaped to receiveand guide the guidewire 406 and the delivery shaft 404, respectively.The hub 430 is arranged in a y-shape such that the guidewire passage 430extends parallel to the sheath 402 while the delivery shaft passage 432extends at an angle relative to each of the guidewire passage 434 andthe delivery shaft passage 432.

The y-shaped arrangement of the hub 430 is only one arrangementcontemplated by the present disclosure. In other implementations, thedelivery shaft passage 434 and the guidewire passage 432 may beconfigured in other arrangements. In other implementations, the hub 430may also include one or more additional passages adapted to enableinsertion of tools, injection or removal of fluids from within the hub430, flushing of the hub, or various other functions. Moreover, whilethe hub 430 is illustrated in FIG. 38 as having a substantially unitaryconstruction, in other implementations, the hub 430 may include multipleseparate sections that are joined together using appropriate seals andcouplings. For example, the hub 430 may include each of a proximalsection and a distal section similar to the hub 310 illustrated in FIG.32 .

As previously discussed in the context of FIGS. 36-37 , the deliveryshaft 404 includes a distal coupling feature 410 in the form of a malethreaded tip. Accordingly, the hub 430 is adapted to enable rotation ofthe delivery shaft 404 to facilitate coupling and decoupling of thedelivery shaft 404 from the intracorporeal device 450. As illustrated inthe implementation of FIG. 38 , for example, the delivery shaft 404 iscoupled to a knob 440, such as by a set screw 442, such that rotation ofthe knob 440 rotates the delivery shaft 404. So, after theintracorporeal device 450 is positioned at the deployment locationwithin the patient, the knob 440 may be rotated to cause the threads ofthe distal coupling feature 410 to unscrew and ultimately disengage fromthe intracorporeal device 450.

The knob 440 is one example of a feature of the hub 430 adapted toenable manipulation of the delivery shaft 404 and, in particular, tofacilitate disengagement of the delivery shaft 404 from theintracorporeal device 450. In other implementations, the hub 430 mayinclude one or more other features, such as buttons, sliders, knobs,switches, locks, pumps, or the like adapted to manipulate the deliveryshaft 404 and/or the distal coupling feature 410 thereof.

Delivery of an intracorporeal device using the delivery system 400generally includes first inserting the guidewire 406 into the patient.For example, in certain applications an access point is formed, such asby a transcutaneous puncture or cut-down, and a Swan-Ganz or similarguiding catheter is inserted through the access point of the patient anddelivered to the deployment site. The guidewire 406 is then insertedthrough the guiding catheter such that a distal end of the guidewire 406is delivered to the deployment site for the intracorporeal device 450.Once the guidewire 406 is properly located, the guiding catheter isremoved.

Before, during, or after the process of implanting the guidewire 406,the intracorporeal device 450 may be loaded onto the delivery system400. In general, loading includes one or more of inserting the deliveryshaft 404 through the hub 430 and sheath 402 such that the deliveryshaft 404 protrudes from a distal end of the sheath 402 and coupling thedistal coupling feature 410 of the delivery shaft 404 to thecorresponding proximal coupling feature 452 of the intracorporeal device450. In implementations in which the distal coupling feature 410 is amale threaded tip and the proximal coupling feature 452 is acorresponding female threaded hole, for example, the distal couplingfeature 410 of the delivery shaft 404 and the proximal coupling feature452 of the intracorporeal device 450 may be coupled together bycontacting the male threads with the female threads and rotating thedelivery shaft 404 such that the threads engage. In certainimplementations, such rotation is achieved by rotating a knob or similarfeature of the hub 430 to which the delivery shaft 404 is coupled.Accordingly, the loading process may further include coupling thedelivery shaft 404 to the knob 440 of the hub 430. As previouslydiscussed, coupling of the delivery shaft 404 to the intracorporealdevice 450 may be accomplished using other arrangements of couplingmechanisms other than a threaded connection. In such implementations,the loading process generally includes coupling the delivery shaft 404to the intracorporeal device 450 according to the specific couplingmechanisms of the implementation. Such coupling may include manipulationof one or more features of the hub 430 adapted to manipulate thecoupling feature of the delivery shaft 404 or to otherwise controlrelease of the coupling between the delivery shaft 404 and theintracorporeal device 450.

Once loaded with the intracorporeal device 450, the delivery system 400is loaded onto the guidewire 406. In general, this process involvesinserting a proximal end of the guidewire 406 into a lumen of the sheath402 (such as the guidewire lumen 408) and passing the delivery catheter404 and the hub 430 along the guidewire 406 such that a distal end ofthe delivery shaft 404 is positioned at the deployment location for theintracorporeal device 450. Once so positioned, the intracorporeal device450 is released from the delivery shaft 404. In the current example,such deployment is achieved by withdrawing the guidewire 406 from theguide 456 of the intracorporeal device 450 (and optionally from thepatient entirely) then counter-rotating the delivery shaft 404, therebyunscrewing the distal coupling feature 410 of the delivery shaft 404 andthe proximal coupling feature 452 from the intracorporeal device 450.Once fully unscrewed, the intracorporeal device 450 is released from thedelivery shaft 404 and the sheath 402, delivery shaft 404, and guidewire110 may be extracted from the patient, leaving the intracorporeal device450 in place.

As previously noted, the sheath 402 may be configured to have oversizedlumens for receiving the guidewire 406 or delivery shaft 404 oradditional lumens adapted to enable one or more of the introduction ofadditional tools, injection of fluid into the patient, withdrawal offluid from the patient, obtainment of pressure or other physiologicalmeasurements, and similar additional functionality. Accordingly, anysuch functions may be performed during the course of the delivery of theintracorporeal device 450 with the delivery system 400. For example,during delivery of the intracorporeal device 450, an initial pressurereading may be taken to confirm that the patient is stable and/or thatno local irregularities are present at the deployment location of theintracorporeal device 450. As another example, contrast media may beperiodically injected through the sheath 402 as the delivery system 400is moved along the guidewire 406 to confirm (using fluoroscopy or asimilar system) the progress of the intracorporeal device 450 and todetermine if and when the intracorporeal device 450 is located at itsfinal deployment location.

Unless otherwise stated, terms used herein such as “top,” “bottom,”“upper,” “lower,” “left,” “right,” “front,” “back,” “proximal,”“distal,” and the like, are used only for convenience of description andare not intended to limit the scope of this disclosure to any particularorientation.

As for additional details pertinent to the present disclosure, materialsand manufacturing techniques may be employed as within the level ofthose with skill in the relevant art. The same may hold true withrespect to method-based aspects of the invention in terms of additionalacts commonly or logically employed. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein. Likewise, reference to a singular item,includes the possibility that there are plural of the same itemspresent. More specifically, as used herein and in the appended claims,the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like, inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

Finally, it will be understood that the embodiments herein have beendisclosed by way of example, and that other modifications may occur tothose skilled in the art without departing from the scope and spirit ofthe appended claims.

What is claimed is:
 1. An intracorporeal device comprising a proximalcoupling feature and a device body, wherein the intracorporeal device isa pressure sensor configured to be located and fixed at a deploymentsite in a vessel; a guidewire; a delivery catheter comprising a distalcoupling feature configured to be coupled to the proximal couplingfeature; a sheath adapted to receive the guidewire and the deliverycatheter; and a lumen provided in at least one of the sheath or deliverycatheter, the lumen having a proximal end and a distal end, the distalend proximate to the deployment site, the lumen having a cross-sectionalarea sufficient and configured to be utilized as a conduit from whichpressure measurements are obtained at the deployment site after thedistal coupling feature of the delivery catheter is decoupled from theproximal coupling feature of the intracorporeal device and while adistal end of the delivery catheter remains proximate to the deploymentsite.
 2. The intracorporeal device delivery system of claim 1, furthercomprising a hub coupled to a proximal end of at least one of the sheathor the delivery catheter.
 3. The intracorporeal device delivery systemof claim 1, wherein the sheath includes the lumen, the lumen furthercomprising a delivery catheter lumen and a guidewire lumen separate fromthe delivery catheter lumen, both in the sheath.
 4. The intracorporealdevice delivery system of claim 3, wherein the sheath includes thelumen, the lumen having a cross-sectional area greater than across-sectional area of the delivery catheter such that an annularvolume is defined between the delivery catheter and a wall of thedelivery catheter lumen, the annular volume sufficient and configured tobe utilized as the conduit from which pressure measurements are obtainedat the deployment site after the distal coupling feature of the deliverycatheter is decoupled from the proximal coupling feature of theintracorporeal device and while a distal end of the delivery catheterremains proximate to the deployment site.
 5. The intracorporeal devicedelivery system of claim 1, wherein the lumen further comprises firstand second lumen, the first lumen provided in the sheath and configuredto receive the delivery catheter, the second lumen provided in thedelivery catheter.
 6. The intracorporeal device delivery system of claim1, further comprising a hub at a proximal end of the lumen, the hub andproximal end of the lumen configured to communicate with a gauge toobtain the pressure measurements, through the lumen, at the deploymentsite.
 7. The intracorporeal device delivery system of claim 6, whereinthe hub comprises a shaft manipulation feature coupled to the deliverycatheter, the shaft manipulation feature configured to release thedistal coupling feature from the proximal coupling feature.
 8. Theintracorporeal device delivery system of claim 7, wherein the shaftmanipulation feature is a rotatable knob coupled to the delivery shaftsuch that rotation of the rotatable knob rotates the delivery shaft todecouple the distal coupling feature from the proximal coupling feature.9. The intracorporeal device delivery system of claim 6, wherein the hubcomprises at least one port in communication with an auxiliary lumensuch that the port is in fluid communication with a distal end of theauxiliary lumen.
 10. The intracorporeal device delivery system of claim9, wherein the auxiliary lumen is a delivery shaft lumen in the sheath.11. A method for delivering an intracorporeal device, comprising:advancing a sheath and a guidewire along vasculature to a deploymentsite; providing the intracorporeal device comprising a proximal couplingfeature and a device body, wherein the intracorporeal device is apressure sensor; coupling a distal coupling feature of a deliverycatheter to the proximal coupling feature of the intracorporeal device;at least one of the sheath or delivery catheter including a lumen havinga proximal end and a distal end, inserting a proximal end of theguidewire into the delivery catheter and translating the deliverycatheter along the guidewire such that the intracorporeal device and thedistal end of the lumen are proximate to the deployment site; decouplingthe distal coupling feature of the delivery catheter from the proximalcoupling feature of the intracorporeal device; and after the decoupling,and while a distal end of the delivery catheter remains proximate to thedeployment site, utilizing the lumen as a conduit to obtain pressuremeasurements.
 12. The method of claim 11, further comprising providing ahub coupled to a proximal end of at least one of the sheath or thedelivery catheter.
 13. The method of claim 11, wherein the sheathincludes the lumen, the lumen further comprising a delivery catheterlumen and a guidewire lumen separate from the delivery catheter lumen,both in the sheath, the method further comprising advancing the sheathover the guidewire and advancing the delivery catheter along thedelivery catheter lumen.
 14. The method of claim 13, further comprisingproviding the lumen in the sheath with a cross-sectional area greaterthan a cross-sectional area of the delivery catheter such that anannular volume is defined between the delivery catheter and a wall ofthe delivery catheter lumen, the annular volume sufficient to beutilized as the conduit from which pressure measurements are obtained atthe deployment site after the distal coupling feature of the deliverycatheter is decoupled from the proximal coupling feature of theintracorporeal device and while a distal end of the delivery catheterremains proximate to the deployment site.
 15. The method of claim 11,further comprising providing a first lumen in the sheath to receive thedelivery catheter and providing a second lumen in the delivery catheter.16. The method of claim 11, further comprising providing a hub at aproximal end of the lumen; coupling a gauge in communication with thehub and proximal end of the lumen; and utilizing the gauge to obtain thepressure measurements, through the lumen, at the deployment site. 17.The method of claim 16, wherein the hub comprises a shaft manipulationfeature coupled to the delivery catheter, the method further comprisingutilizing the shaft manipulation feature to release the distal couplingfeature from the proximal coupling feature.
 18. The method of claim 17,wherein the shaft manipulation feature is a rotatable knob coupled tothe delivery shaft such that rotation of the rotatable knob rotates thedelivery shaft to decouple the distal coupling feature from the proximalcoupling feature.
 19. The method of claim 16, wherein the hub comprisesat least one port in communication with an auxiliary lumen such that theport is in fluid communication with a distal end of the auxiliary lumen.20. The method of claim 19, wherein the auxiliary lumen is a deliveryshaft lumen in the sheath.